What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 00043/0188.

Dovonex Cream

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dovonex® Cream

calcipotriol

Please read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
  • In this leaflet Dovonex® Cream will be called Dovonex®.

In this leaflet:

1. What Dovonex® is and what it is used for
2. Before you use Dovonex®
3. How to use Dovonex®
4. Possible side effects
5. How to store Dovonex®
6. Further information

1. WHAT DOVONEX® IS AND WHAT IT IS USED FOR

Dovonex® belongs to a group of medicines called anti-psoriatics. It is a type of vitamin D.

Vitamin D controls how the cells in your skin grow.

If the cells in your skin grow too much you may get psoriasis. Psoriasis is a condition where your skin develops raised red patches and silver coloured scaly patches. The scaly patches are dead cells that would normally fall off your skin without you noticing.

Dovonex® works by reducing the amount of cells your skin makes. This means your skin symptoms will reduce too.

These diagrams explain how your skin may improve when you use this medicine.

Your skin before treatment.

After about two weeks you may see a change in your skin. The scaly or flaky patches usually clear up first. They will feel smoother.

The redness of the skin will start to clear up next. It may clear up in the centre first.

Dovonex® is used to treat:

  • Plaque psoriasis (psoriasis vulgaris).

2. BEFORE YOU USE DOVONEX®

Do not use Dovonex®

  • If you are allergic (hypersensitive) to calcipotriol or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.
  • If you have been told by a doctor that you have high or low levels of a substance called calcium in your body (calcium metabolism disorders).
  • If you have severe kidney problems.
  • If you have severe liver problems.

Take special care with Dovonex®

Before you use Dovonex® tell your doctor:

  • If you are already having ultraviolet (UV) light treatment. You must discuss with your doctor about having light treatment and using Dovonex® at the same time.
  • If you know you have a type of psoriasis called generalised pustular psoriasis. Ask your doctor if you are unsure.
  • If you know you have a type of psoriasis called erythrodermic exfoliative psoriasis. Ask your doctor if you are unsure.

Do not use Dovonex® on your face.

Your doctor may tell you to limit your exposure to natural or artificial sunlight while you are using this medicine.

You may get too much calcium in your blood when you use this medicine. Please read section 4 of this leaflet so that you can spot any signs this may be happening to you. Your doctor may need to change your dose.

You are not likely to get too much calcium in your blood if you use the dose prescribed for you. You can find the dose that you should use in section 3 of this leaflet. You are more likely to get too much calcium in your blood if you use more than the recommended dose each week.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

You must tell your doctor or pharmacist if you are taking any of the following medicines:

  • Any other medicines to treat psoriasis.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before using Dovonex®:

  • If you are pregnant, or think you are pregnant.
  • If you are breast-feeding.

Tell your doctor if you become pregnant while using this medicine.

If your doctor has agreed that you can breast-feed, do not apply Dovonex® to the breast area.

Driving and using machines

Usually your medicine may have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.

Important information about some of the ingredients of Dovonex®

Dovonex® contains:

  • Cetostearyl alcohol. This may give you an itchy rash and inflammation on your skin where your medicine is used.

Please ask your doctor if you are worried about any of the ingredients in this medicine.

3. HOW TO USE DOVONEX®

Always use Dovonex® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How to put on Dovonex®

This medicine is only for using on your skin or the skin of a child. Do not swallow it. Do not put it inside your body.

Never put this medicine on your face or the face of your child as it may cause irritation.

Do not mix Dovonex® with any other medicines.

Remove the cap. Check the seal is not broken before you first use the cream. If you have a 60 grams or 120 grams tube, you will need to break the seal by using the point in the back of the cap.

Always wash your hands before using Dovonex®.

Put your medicine on the skin which has the psoriasis. You can squeeze your medicine on to your skin directly. You can squeeze it on to your finger first if you wish. Put your medicine on thickly. Then rub it in gently to cover the psoriasis.

Always wash your hands after using Dovonex®. This will stop any medicine accidentally spreading to other parts of your body. Do not worry if you accidentally get any cream on your normal skin, but wash it off if it spreads too far.

Unless you are using the cream to treat your hands, always wash your hands after using Dovonex®.

You should try to keep your skin well moisturised particularly after a bath or shower. If you use a moisturiser wait for it to soak in before you use your medicine.

How much Dovonex® to use

Your doctor will tell you how much Dovonex® to use, or give to your child.

For the best results you should use Dovonex® twice each day. If you are an adult, your doctor may suggest you use the medicine once a day. If you use it twice a day, use it in the morning and in the evening. To remind you to use your medicine it may help to use it when you do another regular action, such as brushing your teeth.

Adults:

Your dose will depend on how bad your psoriasis is.

Your doctor will prescribe the dose that is right for you.

Use the medicine once or twice each day. Follow the advice of your doctor.

Do not use more than 100 grams each week.

Children:

The dose will depend on how bad the psoriasis is. Your doctor will prescribe the dose that is right for your child.

  • Children over 12 years old:
    Use the medicine twice each day.
    Do not use more than 75 grams each week.
  • Children between 6 and 12 years old:
    Use the medicine twice each day.
    Do not use more than 50 grams each week.
  • Children under 6 years old:
    Always refer to your doctor for advice.

If you use more Dovonex® than you should

Tell your doctor straight away.

You may get too much calcium in your blood. Please read section 4 of this leaflet so you can spot any signs that this may be happening to you.

If you forget to use Dovonex®

If you forget to use your medicine, use it as soon as you remember. Then next use your medicine at the usual time.

If you have any further questions about taking this medicine, please ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dovonex® can cause side effects, although not everybody gets them.

Important side effects to look out for:

You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:

  • You have difficulty breathing
  • Your face including around your eyes swell
  • Your skin develops a severe rash.

You should tell your doctor straight away if you spot any of the following signs which may be due to too much calcium in your blood:

  • You need to pass water (urine) more often
  • You feel thirsty
  • You have a dry mouth or a metallic taste in your mouth
  • You feel weak or have pain in your muscles or bones
  • You have a headache
  • You feel sick or have constipation.

Other possible side effects:

The possible side effects in the following section of this leaflet are usually mild.

Very common side effects (probably affect more than 1 in 10 people)

  • Skin irritation

Common side effects (probably affect up to 1 in 10 people)

  • Rash
  • Burning or stinging feeling
  • Dry skin
  • Itching skin
  • Redness
  • Itchy rash and skin inflammation in the area where the medicine is used.

Uncommon side effects (probably affect less than 1 in 100 people)

  • Worsening of your psoriasis.
  • Red, itchy, scaly rash. Blisters may form. These may weep or become crusty (eczema).

Side effects where the number of people affected is not known

  • Itchy raised rash (hives).
  • Temporary changes in your skin colour.
  • Temporary increased sensitivity to sunlight.

If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5. HOW TO STORE DOVONEX®

  • Keep out of the reach and the sight of children.
  • Do not use Dovonex® after the expiry date on the carton. The expiry date is the last day of that month.
  • Store below 25°C.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore.

If you do this you will help protect the environment.

6. FURTHER INFORMATION

What Dovonex® contains

  • The active ingredient is calcipotriol.
    Dovonex® contains 50 micrograms of calcipotriol in each gram of cream.
  • The other ingredients are cetostearyl alcohol, chloroallylhexaminium chloride, disodium edetate, disodium phosphate dihydrate, glycerol 85%, liquid paraffin, macrogol cetostearyl ether, sodium hydroxide, purified water and white soft paraffin.

You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.

What Dovonex® looks like and contents of the pack

Dovonex® is a white cream.

Dovonex® comes in tubes of 60 grams and 120 grams.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

LEO Laboratories Limited
Princes Risborough
Bucks.
HP27 9RR
UK

Manufacturer:

LEO Laboratories Limited
Dublin 12
Ireland

This leaflet was last revised in July 2010.

This leaflet was last approved in October 2010.

More about psoriasis

You can get psoriasis anywhere on your body.

Psoriasis is not infectious so you do not need to worry about other people catching it from you.

We still do not know what causes psoriasis but you can inherit it. Other things can make psoriasis worse such as stress.

For further information about psoriasis, you can contact:

The Psoriasis Association.

mail@psoriasis-association.org.uk

If you have any questions about your treatment, ask your doctor or pharmacist.

®Registered Trade Mark

LEO

009687-11